The hypothesis for this study is that bilateral sacral neuromodulation will improve symptoms of interstitial cystitis by at least 25% when compared to unilateral sacral neuromodulation as reported by patient's responses to the Interstitial Cystitis Symptom and Problem Indices.

This study will be a prospective randomized study comparing bilateral to unilateral sacral neuromodulation. The study population will include all patients diagnosed with interstitial cystitis, using the NIDDK criteria, having staged sacral neuromodulator stimulators placed at Hahnemann University Hospital.

To determine if bilateral sacral neuromodulation will reduce the patient's score on the Interstitial Cystitis Symptom and Problem Questionnaire by at least 25% when compared to unilateral sacral neuromodulation in patients with interstitial cystitis. [ Time Frame: Post-op, at 6 weeks and at 3 months post-surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine if bilateral sacral neuromodulation will improve the patient's voiding diary defined as reduction in urinary frequency by 25% from baseline when compared to unilateral sacral neuromodulation in patients with interstitial cystitis [ Time Frame: Post-op, at 6 weeks and 3 months post-surgery ] [ Designated as safety issue: No ]

Symptoms of urinary frequency (>8 episodes/day as recorded on a voiding diary)

Symptoms of pelvic pain (>4 on the visual analog scale for pelvic pain).

Interstitial Cystitis refractory to more conservative treatments such as behavioral modification, dietary intervention, or medical therapy for at least 6 months.

Able to make medical decisions for herself.

Presence of either glomerulations of Hunner's ulcer on cystoscopic examination.

Participant must agree to use a medically acceptable method of contraception throughout the entire study period, and for 7 days after the study period. Medically acceptable methods of contraception include abstinence, birth control pills or patches, diaphragm with spermicide, IUD, condom with vaginal spermicide, surgical sterilization, post menopausal for at least 1 year, implants or injections, or vasectomized partner.

Must give written informed consent to participate in this study.

Exclusion Criteria:

Prior sacral neuromodulation.

Participant is currently pregnant or breastfeeding.

Male.

Urinary retention (defined by post void residual greater than 100cc).

Neurologic deficit.

Need for future MRI surveillance.

Involved in any study within the past thirty days or currently enrolled.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00590473